EP1641616B1 - Contenant a fort effet de barriere contre l'humidite pour compositions medicales liquides - Google Patents

Contenant a fort effet de barriere contre l'humidite pour compositions medicales liquides Download PDF

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Publication number
EP1641616B1
EP1641616B1 EP04738937A EP04738937A EP1641616B1 EP 1641616 B1 EP1641616 B1 EP 1641616B1 EP 04738937 A EP04738937 A EP 04738937A EP 04738937 A EP04738937 A EP 04738937A EP 1641616 B1 EP1641616 B1 EP 1641616B1
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EP
European Patent Office
Prior art keywords
container
liquid
layer
container according
preferred
Prior art date
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Expired - Lifetime
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EP04738937A
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German (de)
English (en)
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EP1641616A1 (fr
Inventor
Nils Berg Madsen
John Stern Nielsen
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Novo Nordisk AS
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Novo Nordisk AS
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Priority to PL04738937T priority Critical patent/PL1641616T3/pl
Priority to EP10178128A priority patent/EP2301749A1/fr
Publication of EP1641616A1 publication Critical patent/EP1641616A1/fr
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Publication of EP1641616B1 publication Critical patent/EP1641616B1/fr
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B27/08—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B1/00—Layered products having a non-planar shape
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B1/00—Layered products having a non-planar shape
    • B32B1/08—Tubular products
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/28—Layered products comprising a layer of synthetic resin comprising synthetic resins not wholly covered by any one of the sub-groups B32B27/30 - B32B27/42
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/30—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers
    • B32B27/304—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers comprising vinyl halide (co)polymers, e.g. PVC, PVDC, PVF, PVDF
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/40—Properties of the layers or laminate having particular optical properties
    • B32B2307/412—Transparent
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/70—Other properties
    • B32B2307/724—Permeability to gases, adsorption
    • B32B2307/7242—Non-permeable
    • B32B2307/7246—Water vapor barrier
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2323/00—Polyalkenes
    • B32B2323/04—Polyethylene
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2323/00—Polyalkenes
    • B32B2323/10—Polypropylene
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2327/00—Polyvinylhalogenides
    • B32B2327/12—Polyvinylhalogenides containing fluorine
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2439/00—Containers; Receptacles
    • B32B2439/80—Medical packaging
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1334—Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]

Definitions

  • the present invention relates to a transparent plastic container which can be used to storage of liquid solutions or suspensions, for example of medicaments, optionally containing preservatives.
  • Some medicaments are delivered to the patients in solid form, other in liquid form. Often, the liquid medicaments are delivered in a container. Some container consists only or mainly of glass, other consists only or mainly of other materials such as plastic.
  • Medicaments in solid form are often marketed in a glass container or a plastic container.
  • An example of a plastic container is a blister package.
  • a pharmaceutical composition in liquid form the active ingredient is present in dissolved or suspended form.
  • a pharmaceutical composition may contain a pharmaceutically active carrier, a disintegrator, a stabilizer, or a buffer substance.
  • the route of administration varies between the different medicaments. Some medicaments are administered via the oral route, other are administered by injecting the medicament to the patient, for example, intravenously or subcutaneously. Many medicaments being peptides, for example, insulin, are administered by injections. Earlier, syringes were used for the injections. As far as insulin is concerned, it is becoming more and more common to use so called pen systems for the injections. Furthermore, the use of pumps for administration by injection may become a popular way of administrations by injections.
  • the aqueous composition will be present in a glass reservoir or another hard reservoir, in other pumps, aqueous compositions will be present in a flexible reservoir, for example a reservoir which is wholly or mainly made of another material than glass, for example of plastic.
  • a main task for the inventors of this invention has been to find a material or combination of materials which can be used to prepare a transparent, flexible container fulfilling the safety requirements for storage of pharmaceutical solutions containing a preservative such as phenol, m-cresol and benzyl alcohol. It was extremely difficult to find a material fulfilling these requirements.
  • the transparent film (64) exhibits barrier properties which - to a certain degree - protects solution from vapour and oxygen permeation. Furthermore, as long as the peelable layer (55) in US 2003/047467 is not peeled away, the container is not transparent. In US 2003/047467 , there is no statement about properties against preservatives such as phenol, m-cresol and benzyl alcohol.
  • the object of this invention is to overcome or ameliorate at least some of the disadvantages of the prior art. Hence, not all the objects mentioned below may be fully overcome or ameliorated.
  • a more specific object of this invention is to furnish a container or reservoir.
  • Another object of this invention is to furnish a flexible container.
  • Another object of this invention is to furnish a transparent container.
  • Another object of this invention is to furnish a part allowing sterilization.
  • Another object of this invention is to furnish materials which may be welded to itself to form the above mentioned reservoir.
  • Another object of this invention is to furnish a container which can be used for storage of liquid solutions or suspensions of medicaments, optionally containing preservatives.
  • Another object of this invention is to furnish a container which has a sufficient transparency so as to enable inspection of the content of the container.
  • Another object of this invention is to furnish a container which can be used to storage of liquid solutions or suspensions of medicaments, optionally containing preservatives and which container not or only to a minor degree consists of glass.
  • Another object of this invention is to furnish a container having barrier properties securing that the concentration of the active ingredient in the aqueous composition is not changed substantially during storage for a sufficient period of time.
  • Another object of this invention is to furnish a container having barrier properties securing that the concentration of any preservative present in the aqueous composition is not changed substantially during storage for a sufficient period of time.
  • Another object of this invention is to furnish a container which can be welded tightly against a suitable septum material.
  • Another object of this invention is to furnish a container which can be adhered tightly against a suitable septum material by other means than welding.
  • a further object of this invention is to furnish a film for a pouch which can be used for storage of sterile water based drug formulation.
  • a further object of this invention is to furnish a pouch which can be used as reservoir for a pump and, preferably, said reservoir contains a water based drug formulation.
  • a further object of this invention is to furnish a film material for said pouch fulfilling certain functional requirements such as physical properties for the material after sterilization, chemical requirements for the material after sterilization, and cleanliness.
  • one object of this invention is to furnish a film material for said pouch which can be sterilized, for example, using gamma irradiation, electron beam, steam, or ethylene oxide.
  • a further object of this invention is to furnish a film material for said pouch which, after sterilization, fulfils most of or all the following physical requirements: 1) the material must be transparent, 2) the material must provide a good barrier against water; 3) the material must provide a good barrier against gasses (for example, oxygen and carbon dioxide); 4) the material must provide a good barrier against preservatives (for example, phenol and meta-cresol); 5) the material must provide a good barrier against odors (for example preservatives); 6) the material must be resistant against environmental stress cracking (for example, oils, perfumes); 7) the material must be resistant against flex-crack; 8) the material must have good sealing properties (for example, by welding); 9) the material must not delaminate after sterilization, during processing or storage; and 10) the material must not relax significantly during storage and use.
  • a further object of this invention is to furnish a film material for said pouch which, after sterilization, fulfils most of or all the following chemical requirements: 1) the material must not emit substances to the drug which can affect the health and safety of the patient (leachables); 2) the material must have a very low level of extractables; and 3) the material must be compatible with the drug formulation.
  • a further object of this invention is to furnish a film material for said pouch which, after sterilization, fulfils the following requirements for cleanliness: 1) it shall be possible to prepare the material under hygienic conditions; and 2) the final product must be free of dust and particles.
  • a further object of this invention is to furnish a film for said pouch fulfilling certain health and safety requirements, preferably most of or all the requirements mentioned in 1) European Pharmacopoeia (Ph. Eur.) 2002, 4th edition; 2 ) The United States Pharmacopeia (USP) 25; 3) Japanese Pharmacopeia (JP) XIV; 4) EEC Directive 90/128 + amendments "Relating to plastics materials and articles intended to come into contact with foodstuffs"; 5) Code of federal regulations (CFR) Title 21 Food and Drugs, part 170 - 190; 6) III/9090/90 EN. Plastic Primary Packaging Materials. Note for Guidance; and 7) Guidance for Industry. Container Closure Systems for Packaging Human Drugs and Biologics, Chemistry, Manufacturing, and Controls Documentation. FDA, May 1999.
  • Co-extrusion covers a process where two or more polymer materials are melded in two or more extruders and co-extruded together through a flat nozzle or systems of flat nozzles and cooled to form the co-extruded foil.
  • Extrusion-lamination covers a process where a feedstock in form of a foil of one material is coated through a flat nozzle or systems of flat nozzles from one or more extruders with one layer or more layers of melted material or materials and then cooled to form the extrusion-lamination foil.
  • Lamination covers a process, where two feed stocks of foil materials are joined together by adding a proper adhesive to one foil, followed by addition of the second foil forming the laminated foil.
  • a tie layer is a layer which is placed between two polymer layers with the object of securing that the two layers are joined together.
  • container which herein also is designated pouch or reservoir is an item which may contain a liquid.
  • This container is made of a foil or film.
  • the inner layer of the chamber of said container is in intimate contact with the liquid which is to be stored in said container.
  • outer layer of the chamber of said container is a layer which is not in intimate contact with the liquid which is to be stored in said container.
  • the inner layer is placed between the outer layer and said liquid.
  • inner and outer relates to the position of the two layers in relation to each other, the position of the liquid giving the direction of inner and outer.
  • this terminology does not preclude that a further layer can be adhered to the outer layer, at the outside thereof, the result of which being that, in fact, the so-called outer layer is placed between, on one hand, the so-called inner layer and, on the other hand, the additional layer adhered to the so-called outer layer, at the outside thereof.
  • a flexible item is an item that can bend or be bend easily and which does not break (unless it is bend too much). Glass is not flexible.
  • the term flexible in connection with the containers indicates that if the container is subjected to a force, for example, by being filled with a liquid, it will change its form without breaking.
  • insulin refers to insulin from any species such as porcine insulin, bovine insulin, and human insulin and salts thereof such as zinc salts, and protamin salts as well as active derivatives of insulin, and insulin analogues.
  • active derivatives of insulin is what a skilled art worker generally considers derivatives, vide general textbooks, for example, insulin having a substituent not present in the parent insulin molecule.
  • insulin analogues refers to insulin wherein one or more of the amino acid residues have been exchanged with another amino acid residue and/or from which one or more amino acid residue has been deleted and/or from which one or more amino acid residue has been added with the proviso that said insulin analogue has a sufficient insulin activity.
  • any skilled art worker for example, a physician, knows when and which dosages to administer of the insulin analogue.
  • insulin analogues are described in the following patents and equivalents thereto: US 5,618,913 , EP 254,516 , EP 280,534 , US 5,750,497 , and US 6,011,007 .
  • specific insulin analogues are insulin aspart (i.e., Asp B28 human insulin), insulin lispro (i.e., Lys B28 ,Pro B29 human insulin), and insulin glargin (i.e., Gly A21 ,Arg B31 ,Arg B32 human insulin).
  • insulin also covers compounds which can be considered being both an insulin derivative and an insulin analogue. Examples of such compounds are described in the following patents and equivalents thereto: US 5,750,497 , and US 6,011,007 .
  • An example of a specific insulin analogue and derivative is insulin detemir (i.e., des-Thr B30 human insulin ⁇ Lys B29 tetradecanoyl).
  • U refers to insulin units. Most of the currently used (marketed) insulins (bovine, porcine, human, lispro, aspart, and glargine) have a potency of one unit which equals 6 nmol. Long-acting acylated insulins have reduced potency compared to human insulin. Thus, for insulin detemir one unit corresponds to 24 nmol. For other insulins, the relation between U and nmol can be determined, if not known already, for example, by determining the amount giving a similar pharmacological (blood glucose lowering) effect as that of human insulin.
  • blood glucose lowering blood glucose lowering
  • this invention relates to a flexible, transparent, water-tight chamber comprised of a film comprising two layers, an inner layer and an outer layer, wherein the two layers are joined together to form the film and wherein the film is formed into a transparent pouch and wherein the pouch is sufficiently moisture proof, phenol proof and m-cresol proof to allow for extended storage of a medicament solution or suspension containing or consisting of water, phenol and/or m-cresol without significant changes in concentration of water, phenol, and m-cresol occurring over the extended time period and wherein the pouch is radiation sterilisable.
  • a method for storing a liquid solution and/or suspension of insulin for a significant period of time for use in a delivery device comprising the steps of forming a pouch from a transparent polymer film, the film being sufficiently water resistant, phenol resistant, and m-cresol resistant to allow the insulin to age for two years without degradation of its pharmaceutical properties; sterilizing the pouch; and inserting the insulin compound into the pouch for storage for a significant period of time.
  • Figs. 1 & 2 are examples of embodiments of this invention.
  • a container described in the claims below fulfills the requirements set to a container which is to be used for storage of an aqueous solution, especially a solution of a medicament containing preservatives such as phenol or m-cresol.
  • this invention relates to a flexible, at least partially transparent container for storage of a liquid in a water-tight chamber, the wall material of which chamber comprises at least two layers, the inner layer of which is in intimate contact with said liquid when said chamber contains a liquid, and the outer layer which is not, or only to a minor or inferior degree, in contact with said liquid when said chamber contains a liquid, said inner and outer layers being joined intimately together, characterized in that when said chamber is filled with water and when it is stored at a temperature of 5°C for 24 months less than 10 % (weight/weight) of the content of water diffuses out from the container; and when said chamber is filled with water containing 1.8 mg/mL (19 mM) of phenol and when it is stored at a temperature of 5°C for 24 months, the change in the concentration of phenol in the liquid is less than 10 %, and, furthermore, said inner layer consists of a PE or PP film, and either said inner layer and said PCTFE layer being a coextrudate or an ex
  • this invention relates to a flexible, at least partially transparent container for storage of a liquid in a water-tight chamber, the wall material of which chamber comprises at least two layers, the inner layer of which is in intimate contact with said liquid when said chamber contains a liquid, and the outer layer which is not, or only to a minor or inferior degree, in contact with said liquid when said chamber contains a liquid, said inner and outer layers being joined intimately together, characterized in that when said chamber is filled with water and when it is stored at a temperature of 5°C for 24 months less than 10 % (weight/weight) of the content of water diffuses out from the container; and when said chamber is filled with water containing 1.8 mg/mL (19 mM) of phenol and when it is stored at a temperature of 37°C for 12 weeks, the change in the concentration of phenol in the liquid is less than 10 %, and, furthermore, said inner layer consists of a PE or PP film, and either said inner layer and said PCTFE layer being a coextrudate or an ex
  • this invention relates to a container as described above and as claimed herein, wherein the outer layer alone fulfills the requirement that when said chamber is filled with water and when it is stored at a temperature of 5°C for 24 months less than 10 % (weight/weight), preferably less than 5 % (weight/weight), even more preferred less than 3 % (weight/weight) of the content of water diffuses out from the container.
  • the inner layer alone fulfills the requirement that when said chamber is filled with water containing 1.8 mg/mL (19 mM) of phenol and when it is stored at a temperature of 5°C for 24 months, the change in the concentration of phenol in the liquid is less than 10 %; or when said chamber is filled with water containing 1.8 mg/mL (19 mM) of phenol and when it is stored at a temperature of 37°C for 12 weeks, the change in the concentration of phenol in the liquid is less than 10 %.
  • this invention relates to a container as described above and as claimed herein, wherein the inner layer is weldable.
  • the thickness of the inner layer is above 10 ⁇ m, preferably above 20 ⁇ m, and below 60 ⁇ m, preferably below 50 ⁇ m, even more preferred below 40 ⁇ m.
  • this invention relates to a container as described above and as claimed herein, which when filled with water and when stored at a temperature of 5°C for 24 months less than 10 %, preferably less than 5 %, more preferred less than 2 %, (weight/weight) of the content of water diffuses out from the container.
  • this invention relates to a container as described above and as claimed herein, from which when filled with water containing 1.8 mg/mL (19 mM) of phenol and when stored at a temperature of 5°C for 24 months, the change in the concentration of phenol is less than 10 % preferably less than 5 %, more preferred less than 2%.
  • this invention relates to a container as described above and as claimed herein, from which when filled with water containing 1.8 mg/mL (19 mM) of phenol and when stored at a temperature of 37°C for 12 weeks, the change in the concentration of phenol is less than 10 %, preferably less than 5 %, more preferred less than 2 %.
  • this invention relates to a container as described above and as claimed herein, from which when filled with water containing 2.06 mg/mL (19 mM) of m-cresol and when stored at a temperature of 5°C for 24 months, the change in the concentration of m-cresol is less than 10 %, preferably less than 5 %, more preferred less than 2 %.
  • this invention relates to a container as described above and as claimed herein, from which when filled with water containing 2.06 mg/mL (19 mM) of m-cresol and when stored at a temperature of 37°C for 12 weeks, the change in the concentration of m-cresol is less than 10 %, preferably less than 5 %, more preferred less than 2 %.
  • a container as described above and as claimed herein which is prepared from a pouch foil which when tested by test A described below gives a maximum loss of m-cresol of 10%, preferably not more than 5%.
  • a container as described above and as claimed herein which is prepared from a pouch foil which when tested by test A described below gives a change in the pH value which is than +/- 0.2.
  • a container as described above and as claimed herein which is prepared from a pouch foil which when tested by the test B described below gives a maximum weight loss of 2.5%, preferably not more than 1%.
  • a container as described above and as claimed herein which is prepared from a pouch foil which when tested by test B described below gives a maximum loss of m-cresol of 10%, preferably not more than 5%.
  • a container as described above and as claimed herein which is prepared from a pouch foil which when tested by test B described below gives a change in the pH value which is more than +/- 0.2.
  • a container as described above and as claimed herein which is prepared from a pouch foil which when tested by test C described below gives a maximum weight loss of 2.5%, preferably not more than 2%.
  • a container as described above and as claimed herein which is prepared from a pouch foil which when tested by test C described below gives a maximum loss of m-cresol of 10%, preferably not more than 5%.
  • a container as described above and as claimed herein which is prepared from a pouch foil which when tested by test C described below gives a maximum loss of phenol of 10%, preferably not more than 5%.
  • a container as described above and as claimed herein which is prepared from a pouch foil which when tested by test C described below gives a change in the pH value which is not more than +/-0.2.
  • a container as described above and as claimed herein which is prepared from a pouch foil which fulfills test D described below for the dilution 1:50, preferably the dilution 1:100, more preferred the dilution 1:200, even more preferred the dilution 1:400.
  • this invention relates to a container as described above and as claimed herein, which is equipped with a device whereby said liquid can be expelled from said container.
  • this invention relates to a container as described above and as claimed herein, wherein a third polymeric layer is added on the outer side of the PCTFE layer.
  • a container as described above and as claimed herein which, when completely filled with liquid, can contain an amount of liquid which is at least 0.5 ml, preferably at least 1 ml, and not more than 10 ml, preferably not more than 5 ml, more preferred not more than 2 ml and, preferably, the volume is 1.5 ml.
  • this invention relates to a container as described above and as claimed herein, which is filled partially or wholly with a liquid pharmaceutical composition.
  • this invention relates to a container as described above and as claimed herein, wherein at least 95 % (volume/volume), preferably at least 98 % (volume/volume), more preferred at least 99 % (volume/volume), and even more preferred at least 99.9 % (volume/volume), of the inner of the container contains the liquid pharmaceutical composition
  • this invention relates to a container as described above and as claimed herein, which is filled partially or wholly with a liquid pharmaceutical composition wherein the active ingredient is a peptide.
  • this invention relates to a container as described above and as claimed herein, which is filled partially or wholly with a liquid pharmaceutical composition wherein the active ingredient is insulin.
  • this invention relates to a container as described above and as claimed herein, wherein the content of insulin in said container is in the range from 10 U/ml to 1500 U/ml.
  • this invention relates to a container as described above and as claimed herein, containing a solution or suspension containing a preservative.
  • this invention relates to a container as described above and as claimed herein, which is filled partially or wholly with a liquid pharmaceutical composition containing phenol.
  • this invention relates to a container as described above and as claimed herein, which is filled partially or wholly with a liquid pharmaceutical composition containing m-cresol.
  • this invention relates to a container as described above and as claimed herein, which is filled partially or wholly with a liquid pharmaceutical composition containing benzyl alcohol.
  • this invention relates to the use of a container as claimed herein for storing a liquid pharmaceutical composition mentioned in any of the claims 12-18.
  • this invention relates to a container for storage of a liquid in a water-tight chamber, the wall material of which chamber comprises at least two layers, the inner layer of which is in intimate contact with said liquid when said chamber contains a liquid, and another layer consisting of a PCTFE film which is not, or only to a minor or inferior degree, in contact with said liquid when said chamber contains a liquid, said inner layer consisting of a PE or PP film, and either said inner layer and said PCTFE layer being a coextrudate or an extrusion-laminate or said inner layer and said PCTFE layer being joined together, and the thickness of said PCTFE layer being above 40 ⁇ m, and being below 100 ⁇ m, preferably below 75 ⁇ m, and which container is filled partially or wholly with a liquid pharmaceutical composition wherein the active ingredient is a peptide.
  • this invention relates to a container as described above and as claimed herein, which is at least partially transparent.
  • this invention relates to a container as described above and as claimed herein, which is wholly transparent.
  • the inner layer of the container of this invention may consist of polyethylene (herein designated PE) or polypropylene (herein designated PE) or mixtures of PE and PP.
  • PE consists of at least 75%, preferably at least 90 %, more preferred at least 95 %, (weight/weight) of polyethylene.
  • PP consists of at least 75%, preferably at least 90 %, more preferred at least 95 %, (weight/weight) of polypropylene.
  • PE is as defined in European Pharmacopoeia 2001, 4th Edition, point 3.1.5 , the content of which is hereby incorporated by reference.
  • Examples of components present in PE are higher alkene homologues (C 3 to C 10 ) and other additives mentioned therein.
  • PP is as defined in European Pharmacopoeia 2001, 4th Editi on, point 3.1.6, the content of which is hereby incorporated by reference.
  • PP consists of the homopolymer of propylene or of a copolymer of propylene with not more than 25% of ethylene or a mixture (alloy) of polypropylene with not more than 25 % of polyethylene. It may contain additives, vide the above point 3.1.6.
  • the inner layer is a PCTFE layer consisting of at least 75%, preferably at least 90 %, more preferred at least 95 %, (weight/weight) of a polychlorotrifluoroethylene film, for example Aclar ® from Honeywell, Morris Town, New Jersey, USA.
  • the outer layer is a PCTFE layer consisting of at least 75%, preferably at least 90 %, more preferred at least 95 %, (weight/weight) of a polychlorotrifluoroethylene film, for example Aclar ® from Honeywell, Morris Town, New Jersey, USA.
  • the tie layer which may be used to secure that the inner and outer layers, e.g. the PCTFE layer, are joined together may consist of an adhesive, for example polyethyleneimine (hereinafter designated PEl) or any other suitable tie layer.
  • PEl polyethyleneimine
  • the tie layer can be a polyolefin having at least one functional moiety of an unsaturated carboxylic acid or an anhydride thereof.
  • the tie layer can be a polyolefin having at least one functional moiety of an unsaturated carboxylic acid or an anhydride thereof. Examples are: Lotader, Lotryl, Evatane and Orevac ex. ATOFINA, Lavamelt ex. BAYER, PROVISTA and EASTAR ex. EASTMAN, Bynel ex. DuPont, AMPLIFY and INTEGRAL ex. Dow.
  • tie layers are mentioned in WO 98/25762 , the content of which is hereby incorporated by reference.
  • reference could also be made to that used in Aclar® Cx 130 from Honeywell.
  • the tie layer is so that only an inferior amount of phenol, m-cresol, or benzyl alcohol disappears during a period of 24 months at a temperature of 5°C or a period of 12 weeks at 27°C months, when an aqueous solution containing 1.8 mg/ml of phenol is placed in a container according to this invention, vide the tests described below.
  • tie layers have a thickness of, for example 2 or 8 ⁇ m. According to a preferred embodiment of this invention, it relates to a container as described above, wherein the tie layer or tie layers in the foil has a thickness in the range from 1 ⁇ m to 10 ⁇ m, preferably below 8 ⁇ m, more preferred below 6 ⁇ m.
  • coex-laminated products is not limited to some of the specific polymer layers mentioned above such as PP or PE and PCTFE.
  • coex-laminated product not made of PP or PE and PCTFE is a coextrudated PE-PET foil laminated to PCTFE which can be prepared by use of standard lamination techniques known in the art. This structure has a remarkable barrier against mobile molecules like m-cresol.
  • a third polymeric layer may be added on the outer side of the outer layer, e.g., on the outer side of the PCTFE layer.
  • a third layer examples of such a third layer are PP, PE, PET-G (polyethylene pthereptate glycerol modified), and TPE (thermoplastic elastomer), allowing welding from the outside of the reservoir.
  • Fig. 5 shows an example where such a third polymeric layer is used.
  • the additional layer may be the same or different from the inner layer.
  • the additional layer and the inner layer are identical or almost identical.
  • the thickness of the inner layer is at least 20 ⁇ m, preferably at least 30 ⁇ m, and the thickness of the inner layer is not more than 100 ⁇ m, preferably not more than 75 ⁇ m.
  • a foil useful to produce a container of this invention consisting of a coextrudate may be prepared as follows:
  • a foil useful to produce a container of this invention consisting of an extrudate-laminate may be prepared as follows:
  • a foil useful to produce a container of this invention consisting of a lamination may be prepared as follows:
  • a container of this invention wherein the two layers are joined together using a welding layer may be prepared as follows:
  • the container according to this invention must have a flexibility which allows filling of the container so that it can be used as a pouch.
  • the aqueous composition contains a preservative it is important that the concentration thereof is sufficient to maintain an antimicrobiological efficacy.
  • the container of this invention consists of a material which enables sterilization of the container in a convenient way, for example, by ⁇ or ⁇ irradiation or by heating.
  • the container of this invention consists of a material which fulfills the following test for flexibility: Two rectangular pieces of the material being tested both having the size 60 mm x 20 mm are welded together with a 3 mm welding zone forming a welded test pouch and, thereafter, 1.5 ml of water is filled into the pouch. If the overpressure is below 100 mBar, the material has a sufficient flexibility.
  • the container of this invention is to be used for storage of an aqueous pharmaceutical composition, optionally a solution or suspension of a pharmaceutically active compound.
  • the active ingredient in said pharmaceutical composition is a protein.
  • the active ingredient is insulin, growth hormone or factor VII and analogs thereof.
  • the amount of insulin in the aqueous solution or suspension is in the range with the lower limit being 10 U/ml, preferably 40 U/ml, more preferred 100 U/ml, and even more preferred 150 U/ml, and the upper limit being 1500 U/ml, preferably 1000 U/ml, more preferred 500 U/ml, even more preferred 300 U/ml.
  • the aqueous formulation contains a stabilizer. In a more preferred embodiment of this invention, the aqueous formulation contains phenol. In another preferred embodiment of this invention, the aqueous formulation contains m-cresol. In another preferred embodiment of this invention, the aqueous formulation contains benzyl alcohol. In a further preferred embodiment of this invention, the total concentration of phenol and/or m-cresol in the aqueous formulation is in the range from 20 mM to 50 mM, preferably in the range from 30 mM to 45 mM. The concentration of phenol and/or m-cresol is, inter alia, depending on the concentration of insulin in the aqueous formulation.
  • the amount of phenol in the aqueous solution is in the range from 15 to 25 mM. In another preferred embodiment of this invention, the amount of m-cresol in the aqueous solution is in the range from 15 to 25 mM. In another preferred embodiment of this invention, the amount of benzyl alcohol in the aqueous formulation is in the range from 15 to 25 mM. In another preferred embodiment of this invention, there is no benzyl alcohol present in the aqueous formulation.
  • the container of this invention may be equipped with a device whereby said liquid can be expelled from said container (when desired).
  • a device whereby said liquid can be expelled from said container (when desired).
  • An example of such a device can be a septum for needle penetration in the form of a rubber material adhered on the inside or on the outside of the container foil or in the welding zone between the two foils.
  • Another example can be an active or a passive closure valve adhered to the container.
  • the container of this invention may be emptied by application of external pressure to the reservoir or by suction from a pump device.
  • the container of this invention can be used in many devices, for example, a pump, a syringe, or a pen like syringe. Conveniently, the container of this invention is disposable.
  • a film material comprising at least two layers, said layers being joined intimately together, can be used for preparing a transparent container according to this invention.
  • Such a film material can be used directly to prepare the containers claimed herein.
  • such a film material shall not be processed so that a further film is attached to the whole of one of the two surfaces.
  • the container of this invention is prepared from pouch foils fulfilling some or all of the following tests:
  • the foil is subjected to irradiation with 2 x 25 kGy e-beam on a number of planear A4 sheets having a total thickness less than 1 cm.
  • 10 cm 2 (2 x 5 cm 2 ) of the foil is cut into 15 minor parts sized (0.7 x 1 cm 2 ) and immersed into 1.5 ml of a solution containing about 1.80 mg/mL (19 mM) phenol, 2.06 mg/mL (19 mM) m-cresol, 16.0 mg/mL (174 mM) glycerol, 1.25 mg/mL (7 mM) disodium hydrogenphosphat, 0.58 mg/mL (10 mM) sodium chloride and pH: 7.40.
  • the immersed sample and a reference sample are placed in an incubator at 37°C for 1 week.
  • the content of m-cresol in the solution is analyzed by using a chromatographic method.
  • a foil in test is placed between two flanges allowing 10 cm 2 of the inner foil (PE, PP or any other welding layer) to be in contact with 5 ml of a solution containing phenol:about 1.80 mg/mL (19 mM), m-cresol: 2.06 mg/mL (19 mM), glycerol:16.0 mg/mL (174 mM), disodiumhydrogenphosphat:1.25 mg/mL (7 mM), sodium chloride: 0.58 mg/mL (10 mM), and pH: 7.40.
  • the Paddington cup is placed upside down allowing direct contact between the solution and the foil in an incubator at 37°C and a relative humidity of max.
  • the maximum weight loss should be 2.5% preferred less than 1%
  • the maximum loss of m-cresol should be 10% and preferred less than 5%
  • the pH value should not change more than +/- 0.2.
  • pouches are produced by welding the foil and by filling the pouches with vehicle. Some pouches are weighed before storage at 37°C and a relative humidity of 15% and weighed after up till 12 weeks. Some pouches are stored at 37°C and tested for content of m-cresol and phenol at regular intervals up to 12 weeks. Glass vials are used as a reference.
  • the maximum weight loss shall be not more than 2.5%, preferred not more than 2%
  • the maximum loss of m-cresol shall be not more than 10% and preferred not more than 5%
  • the maximum loss of phenol shall be not more than 10% and preferred not more than 5%.
  • the pH value should not change more than +/- 0.2.
  • a filled pouch must fulfill the transparency requirement in the European Pharmacopoeia 2001, 4th Editi on, part 3.2.2.1 concerning plastic containers for aqueous solutions for parenteral infusion.
  • solution S is diluted 1:200 (for PE or PP) or 1:400 for other containers.
  • This test can be modified by testing solution S diluted 1:50 or 1:100.
  • PCTFE co-extruded with epoxy modified polyethylene imine (a tie-layer) and 50 micron of PE.
  • This co-extruded foil is used for preparing the container containing approximately 1.5 ml by heat welding.
  • a co-extrude of PE-PET is laminated using a PU based adhesive to an laminate of Aclar ® UltrR ⁇ 2000 and PET giving a construction like PE-PET/Aclar®UltrR ⁇ 2000/PET, where "/" indicates the use of an adhesive.
  • This co-extruded foil is used for preparing the container containing approximately 1.5 ml by heat welding.
  • the foil consisting of 3 polymers will be useful to produce pouches using the PE welding layer and which allow adhesion of a member consisting of a material allowing welding to the PP layer outside the pouch.

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  • Health & Medical Sciences (AREA)
  • Mechanical Engineering (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Hematology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Bag Frames (AREA)
  • Laminated Bodies (AREA)
  • Packages (AREA)
  • Wrappers (AREA)
  • Compositions Of Macromolecular Compounds (AREA)

Claims (18)

  1. Un conteneur pour le stockage d'un liquide dans une chambre étanche à l'eau, le matériau de paroi de cette chambre comprenant au moins deux couches, dont la couche interne est en contact intime avec ledit liquide lorsque ladite chambre contient un liquide, et une autre couche consistant en un film de PCTFE qui n'est pas, ou n'est qu'à un degré mineur ou inférieur, en contact avec ledit liquide lorsque ladite chambre contient un liquide, ladite couche interne consistant en un film de PE ou de PP, et ladite couche interne et ladite couche de PCTFE étant un co-extrudat ou un stratifié par extrusion, ou bien ladite couche interne et ladite couche de PCTFE étant réunies ensemble, et l'épaisseur de ladite couche de PCTFE étant supérieure à 40 µm, et étant inférieure à 100 µm, de préférence inférieure à 75 µm et le conteneur étant partiellement ou totalement rempli d'une composition pharmaceutique liquide où le principe actif est un peptide.
  2. Le conteneur selon la revendication précédente, qui est au moins partiellement transparent.
  3. Le conteneur selon la revendication précédente, qui est totalement transparent.
  4. Le conteneur selon l'une des revendications précédentes, dans lequel l'épaisseur de la couche interne est supérieure à 10 µm, de préférence supérieure à 20 µm, et inférieure à 60 µm, de préférence inférieure à 50 µm, encore plus préférentiellement inférieure à 40 µm.
  5. Le conteneur selon l'une des revendications précédentes, dans lequel l'épaisseur de la couche de liaison ou des couches de liaison dans la feuille est comprise dans la plage allant de 1 µm à 10 µm, de préférence inférieure à 8 µm, plus préférentiellement inférieure à 6 µm.
  6. Le conteneur selon l'une des revendications précédentes, qui est flexible.
  7. Le conteneur selon l'une des revendications précédentes, conteneur qui est équipé d'un dispositif tel que ledit liquide puisse être expulsé hors dudit conteneur.
  8. Le conteneur selon l'une des revendications précédentes, dans lequel une troisième couche polymère est ajoutée sur la face externe de la couche de PCTFE.
  9. Le conteneur selon l'une des revendications précédentes, conteneur qui, lorsqu'il est complètement rempli de liquide, peut contenir une quantité de liquide qui est d'au moins 0,5 ml, de préférence d'au moins 1 ml, et non supérieure à 10 ml, de préférence non supérieure à 5 ml, très préférablement non supérieure à 2 ml et, de préférence, le volume est de 1,5 ml.
  10. Le conteneur selon l'une des revendications précédentes à l'exception de la précédente, conteneur qui, lorsqu'il est complètement rempli de liquide, peut contenir une quantité de liquide qui est comprise entre 2 ml et 4 ml, de préférence 3 ml.
  11. Une utilisation d'un conteneur selon l'une des revendications ci-dessus pour stocker une composition pharmaceutique liquide mentionnée dans l'une des revendications précédentes.
  12. Une utilisation selon la revendication précédente dans laquelle au moins 95 % (volume/volume), de préférence au moins 98 % (volume/volume), plus préférentiellement au moins 99 % (volume/volume) et encore plus préférentiellement au moins 99,9 % (volume/volume) de l'intérieur du conteneur contient la composition pharmaceutique liquide.
  13. Le conteneur selon les revendications précédentes de produit, où le peptide est l'insuline.
  14. Le conteneur selon la revendication précédente, dans lequel la teneur de l'insuline est dans la plage comprise entre 10 U/ml et 1500 U/ml.
  15. Le conteneur selon l'une des revendications précédentes de produit, contenant un conservateur.
  16. Un conteneur selon l'une des revendications précédentes de produit, rempli totalement ou partiellement d'une composition pharmaceutique liquide contenant du phénol.
  17. Un conteneur selon l'une des revendications précédentes de produit, rempli totalement ou partiellement d'une composition pharmaceutique liquide contenant du m-crésol.
  18. Un conteneur selon l'une des revendications précédentes de produit, rempli totalement ou partiellement d'une composition pharmaceutique liquide contenant de l'alcool benzylique.
EP04738937A 2003-06-27 2004-06-23 Contenant a fort effet de barriere contre l'humidite pour compositions medicales liquides Expired - Lifetime EP1641616B1 (fr)

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PL04738937T PL1641616T3 (pl) 2003-06-27 2004-06-23 Wysoce wilgocioszczelny pojemnik dla medycznych mieszanin ciekłych
EP10178128A EP2301749A1 (fr) 2003-06-27 2004-06-23 Contenant a fort effet de barriere contre l'humidite pour compositions medicales liquides

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DKPA200300971 2003-06-27
US50471503P 2003-09-22 2003-09-22
US52334903P 2003-11-19 2003-11-19
DKPA200301717 2003-11-19
US52479303P 2003-11-25 2003-11-25
DKPA200301741 2003-11-25
US52546903P 2003-11-26 2003-11-26
DKPA200301746 2003-11-26
PCT/DK2004/000440 WO2005000580A1 (fr) 2003-06-27 2004-06-23 Contenant a fort effet de barriere contre l'humidite pour compositions medicales liquides

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EP1641616B1 true EP1641616B1 (fr) 2011-04-13

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EP (2) EP1641616B1 (fr)
JP (1) JP4781264B2 (fr)
KR (1) KR20060029154A (fr)
CN (1) CN1791511A (fr)
AT (1) ATE505323T1 (fr)
AU (1) AU2004251810B2 (fr)
CA (1) CA2529023A1 (fr)
DE (1) DE602004032237D1 (fr)
PL (1) PL1641616T3 (fr)
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US8399078B2 (en) 2013-03-19
WO2005000580A1 (fr) 2005-01-06
ATE505323T1 (de) 2011-04-15
US20060134358A1 (en) 2006-06-22
CA2529023A1 (fr) 2005-01-06
KR20060029154A (ko) 2006-04-04
CN1791511A (zh) 2006-06-21
EP2301749A1 (fr) 2011-03-30
JP2007506464A (ja) 2007-03-22
RU2381103C2 (ru) 2010-02-10
JP4781264B2 (ja) 2011-09-28
RU2005139050A (ru) 2006-06-27
AU2004251810A1 (en) 2005-01-06
EP1641616A1 (fr) 2006-04-05
PL1641616T3 (pl) 2011-09-30
AU2004251810B2 (en) 2010-03-04
DE602004032237D1 (de) 2011-05-26

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